Clinical trial · Interventional
Phase 2 Study MPC-6827 for Recurrent Glioblastoma Multiforme
Phase 2 Study of Azixa (MPC-6827) for the Treatment of Patients With Recurrent Glioblastoma Multiforme
NCT00892931CI-TRIAL-00005634completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and effectiveness of Azixa in patients with recurrent glioblastoma multiforme
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azixa | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the progression-free survival (PFS) rate
- timeFrame
- Six 28-day cycles from start of therapy
Secondary outcomes (2)
- measure
- Overall survival
- timeFrame
- 36 months
- measure
- Overall response rate
- timeFrame
- 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have histologically proven malignant Glioblastoma Multiforme in first or second relapse * Have failed prior Fractionated External Beam Cranial Irradiation or IMRT * Be at least 18 years old and with a life expectancy ≥ 8 weeks or ≥ 4 weeks if failed prior Avastin therapy * Have a Karnofsky performance status of ≥ 60 * Have adequate bone marrow function, liver function, and renal function before starting therapy Exclusion Criteria: * Have had more than two relapses * Have had radiosurgery * Have a cardiac ejection fraction \< 50% by MUGA or ECHO * Have Troponin-I elevated above the normal range * Have an increasing steroid requirement * Have MRI evidence at baseline of enlarging or clinically significant intratumor hemorrhage * Have active stroke and/or transient ischemic attack not optimally managed * Have active cardiovascular disease (e.g. sub-optimally managed angina, impending myocardial infarction, or uncontrolled hypertension) * Be pregnant or breast feeding * Have had prior hypersensitivity reaction to Cremophor EL * Be HIV positive
References
Publications (2)
- BACKGROUNDSirisoma N, Pervin A, Zhang H, Jiang S, Willardsen JA, Anderson MB, Mather G, Pleiman CM, Kasibhatla S, Tseng B, Drewe J, Cai SX. Discovery of N-(4-methoxyphenyl)-N,2-dimethylquinazolin-4-amine, a potent apoptosis inducer and efficacious anticancer agent with high blood brain barrier penetration. J Med Chem. 2009 Apr 23;52(8):2341-51. doi: 10.1021/jm801315b. PMID 19296653
- BACKGROUNDKasibhatla S, Baichwal V, Cai SX, Roth B, Skvortsova I, Skvortsov S, Lukas P, English NM, Sirisoma N, Drewe J, Pervin A, Tseng B, Carlson RO, Pleiman CM. MPC-6827: a small-molecule inhibitor of microtubule formation that is not a substrate for multidrug resistance pumps. Cancer Res. 2007 Jun 15;67(12):5865-71. doi: 10.1158/0008-5472.CAN-07-0127. PMID 17575155